| CTRI Number |
CTRI/2023/08/056089 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to assess the effect of defective front teeth on Quality of life in 11-14 year old children. |
|
Scientific Title of Study
|
To Evaluate the Effect of Anterior Esthetic Defects on the Oral Health Related Quality of Life in 11-14-year-old children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bandaru Suma |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Sai College of Dental Surgery. |
| Address |
Room number 9, Depatment of Pedodontics and Preventive Dentistry, Sri Sai College of Dental Surgery, 1-2-64, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad,501102.
Hyderabad
TELANGANA
501102
India |
| Phone |
9515942887 |
| Fax |
|
| Email |
sumabandaru2k2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarada Penmetcha |
| Designation |
Professor |
| Affiliation |
Sri Sai College of Dental Surgery. |
| Address |
Room number 9, Depatment of Pedodontics and Preventive Dentistry,Sri Sai College of Dental Surgery, 1-2-64, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad,501102.
Hyderabad
TELANGANA
501102
India |
| Phone |
8008116618 |
| Fax |
|
| Email |
drsarada9@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSarada Penmetcha |
| Designation |
Professor |
| Affiliation |
Sri Sai College of Dental Surgery. |
| Address |
Room number 9, Depatment of Pedodontics and Preventive Dentistry,Sri Sai College of Dental Surgery, 1-2-64, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad,501102.
TELANGANA
501102
India |
| Phone |
8008116618 |
| Fax |
|
| Email |
drsarada9@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Sai College of Dental Surgery, 1-2-64, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad,501102. |
|
|
Primary Sponsor
|
| Name |
Dr. Bandaru Suma |
| Address |
Sri Sai College of Dental Surgery, 1-2-64, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad,501102. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bandaru Suma |
Sri Sai College of Dental Surgery |
Room no 9, Department of Pedodontics and Preventive Dentistry,Sri Sai College of Dental Surgery, 1-2-64, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad,501102.
Hyderabad
TELANGANA |
9515942887
sumabandaru2k2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE 2021-22 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 11-14 years.
Children with anterior teeth esthetic defects. |
|
| ExclusionCriteria |
| Details |
Children with physical or mental disability.
Children with long standing systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of anterior esthetic defects on oral health related quality of life in 11-14 year old children. |
To evaluate the effect of anterior esthetic defects on oral health related quality of life in 11-14 year old children. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In facial esthetics, teeth hold a greater share of attention and a dental appearance that deviates from acceptable norms may even negatively affect an individual. Increase in concern towards dental appearance can be observed among schoolchildren too. Therefore, any defect in the anterior teeth may impair not only the outward appearance of the child but also can have a deep impact on the self-esteem of the child. Oral health related quality of life (OHRQoL) is a key component of good health and well-being. It is a multifaceted construct that assess the impact of oral health or diseases on an individual’s routine functioning, contentment or overall quality of life.
|